MeiraGTx Holdings plc has recently released its 10-K report, detailing its financial performance and operational highlights. The company, a clinical stage gene therapy firm, focuses on developing treatments for serious diseases such as ocular diseases, neurodegenerative diseases, and xerostomia. MeiraGTx has a broad pipeline of late-stage clinical programs and has developed end-to-end manufacturing capabilities, including viral vector production facilities and a gene regulation platform technology.
In the year ended December 31, 2023, MeiraGTx reported significant operating losses, with a net loss of $84.0 million, contributing to an accumulated deficit of $554.2 million as of that date. The company has not generated any product revenues to date and does not expect to do so for several years, if at all. It has financed its operations primarily through cash on hand, proceeds from sales of shares, debt financing, and upfront and milestone payments from collaboration agreements.
MeiraGTx's total operating expenses were $151.1 million in 2023, up from $132.3 million in 2022. The company expects to continue incurring increasing costs associated with its clinical activities and research activities in additional therapeutic areas to expand its pipeline. It also anticipates ongoing expenses related to the development of its gene regulation technology and internal manufacturing capabilities.
To secure additional financing, MeiraGTx has pursued various avenues, including private placements and agreements with entities such as Johnson & Johnson Innovation and Sanofi Foreign Participations. The company estimates that its available funds will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of 2026, not including potential milestone payments from collaboration agreements.
Looking ahead, MeiraGTx anticipates the need for additional capital to complete the development and potential commercialization of its product candidates. The company may raise additional funds through equity offerings, debt financings, marketing and distribution arrangements, collaborations, strategic alliances, licensing arrangements, or other sources. However, it acknowledges that adequate additional financing may not be available on acceptable terms, or at all.
In terms of recent developments, MeiraGTx has made significant strides, including entering into an Asset Purchase Agreement with Janssen, which resulted in a non-refundable upfront cash payment of $65.0 million in December 2023 and a milestone payment of $50.0 million in the first quarter of 2024. Additionally, the company received a non-refundable upfront payment of $65.0 million in connection with the Asset Purchase Agreement. Following these announcements, the company's shares moved 9.8%, and are now trading at a price of $6.48. If you want to know more, read the company's complete 10-K report here.
